October 1995 Bulletin

Position Statement - Medical, Surgical Procedure Patents

A "pure" medical or surgical procedure is a medical
diagnostic procedure or treatment, or a method or process, where
the "invention" is independent of the use of a medical
device and drug. For more than a century these medical and surgical
methods and processes for diagnosing and treating disease in both
people and animals were not considered patentable. In 1952, Congress
changed the patent law, adding to the list of subject matter which
could be patented, of "new and useful processes." At
the time, the clear legislative intent was to codify existing
policy, not change it, and "pure" medical and surgical
methods and processes were still not considered patentable.

Since 1952, however, the U.S. Patent and Trademark Office has
been routinely issuing method or process patents for purely medical
and surgical procedures not associated with any drug or medical
device (hereinafter referred to as "Medical Procedure Patents").
Until recently, such patents were rarely enforced. During the
past decade, however, the holders of some of these Medical Procedure
Patents have actively sought to enforce them, and during the last
few years, the number of Medical Procedure Patents has dramatically
increased.

There are several compelling ethical and legal reasons for prohibiting
the patenting of medical and surgical methods and processes.

1. Is it unethical for an orthopaedic surgeon to patent a medical
and surgical procedure which is performed independent of a drug
or device?

3. Should the U.S. Patent and Trademark Office place a moratorium
on the granting of these Medical Procedure Patents?

4. Should Congress amend federal law to prohibit the patenting
of medical and surgical procedures which are performed independent
of a drug or device?

The training of new physicians and continuing medical education
for practicing physicians are based on the free sharing and passing
on of knowledge, methods, and procedures. Since it is in the patent
holder's interest to keep an "invention" a secret until
the patent is granted, Medical Procedure Patents actually discourage
doctors from sharing medical information openly. In addition,
the enforcement of Medical Procedure Patents is a strong disincentive
for physicians to share the results of their professional experiences
and/or independent discoveries of similar existing methods with
their colleagues, since this sharing may identify themselves for
a potential target for infringement suits. Thus, the granting
of Medical Procedure Patents undermines the process of peer review,
evaluation, and critical appraisal of medical innovation within
the medical profession.

It is possible for the medical community to reach an untenable
situation, where all medical schools, and all medical and surgical
societies or other entities providing medical education would
be prohibited from teaching certain procedures or would have to
pay a licensing fee to the inventor before teaching a course that
includes the patented method. The cost of medical education also
will increase if medical schools are required to pay royalties
to patent holders to teach patented surgical and medical techniques.
This serves as an additional disincentive to utilize Medical Procedure
Patents.

Medical Procedure Patents unreasonably interfere with the practice
of medicine and the physician-patient relationship. Enforcing
such Medical Procedure Patents may compromise patient confidentiality
since all procedures will have to be recorded. Also, patients
may be denied access to certain procedures, and their choice of
physicians may be restricted to only
those doctors who are paying royalties to the original "inventor"
of the process. Granting Medical Procedure Patents will adversely
affect the quality of care, impede medical technology, and contribute
to the increasing cost of health care.

In sum, Medical Procedure Patents impede the advancement of medicine,
curtail academic access, compromise peer review, place unreasonable
limits on the research community, directly interfere with the
education of new physicians,
and interfere with the physician-patient relationship and the
quality of medical care provided to the patient. Under these circumstances,
the patenting or protection of "pure" medical procedures
or techniques is unethical. This position is consistent with the
American Medical Association Report of the Council on Ethical
and Judicial Affairs on the Patenting of Medical Procedures.

No medical method or procedure is really "new" or innovative.
Instead, every advancement in medicine, and in medical methods
or procedures builds on existing knowledge. Sufficient "prior
art" exists in almost every instance where the U.S. Patent
and Trademark Office has granted a Medical Procedure Patent. Seen
in this light, the U.S. Patent and Trademark Office should not
have even granted these patents. The consensus in the medical
community is that no medical process is really new. Every method
innovation is largely based on "prior art." Also, there
is the real possibility of expensive litigation over whether a
Medical Procedure Patent should have been granted in the first
place. Such litigation has already occurred in this country and
serves to increase the cost of health care generally.

The U.S. Patent and Trademark Office does not have the staff or
expertise to identify "prior art." Moreover, most medical
methods and procedures have not been patented, and consequently,
the Patent and Trademark Office is ill-equipped to determine whether
a process is new. In most instances, these medical and surgical
processes have existed for years, and have been transferred from
teacher to student through practice seminars, actual "hands-on"
training, and through the medical literature. Therefore, the U.S.
Patent and Trademark Office should place a moratorium on the granting
of these Medical Procedure Patents until such time as it is able
to more efficiently and effectively determine "prior art,"
and whether a Medical Procedure Patent application should be granted.

The consensus of the world community has been to ban these Medical
Procedure Patents. More than 80 countries throughout the world
expressly prohibit Medical Procedure Patents, including most European
countries. The European countries and the United States are cosignatories
of international trade agreements ensuring reciprocity, and for
the U.S. to be in full compliance with these agreements, it should
prohibit Medical Procedure Patents.

Because of the concerns raised by
the medical community, in the 104th Congress, Rep. Greg Ganske,
MD
(R-Iowa) and Rep. Ron Wyden (D-Ore.) introduced a bill, HR 1127,
to amend the current patent law to prohibit the patenting of medical
and surgical procedures.

Consistent with the Code of Ethics and the Principles
of Medical Ethics in Orthpaedic Surgery, and the American
Medical Association's Report of the Council on Ethical and
Judicial Affairs on the Patenting of Medical Procedures, the
American Academy of Orthopaedic Surgeons asserts that it is unethical
for orthopaedic surgeons to seek, secure, or enforce patents on
medical and/or surgical procedures.

The granting of Medical Procedure Patents poses a serious threat
to medical advancement, medical education, and patient care, as
well as contributes to the spiraling costs of health care.

The granting of Medical Procedure Patents conflicts with the
American Academy of Orthopaedic Surgeons' mission to promote and
foster the provision of cost-effective, high quality medical care.

The U.S. Patent and Trademark Office should cease granting
any more Medical Procedure Patents for medical and surgical procedures
until such time as it takes to institute adequate safeguards to
determine that there is no "prior art," rather than
forcing physician defendants to prove "after the fact"
that a Medical Procedure Patent should not have been granted.

The American Academy of Orthopaedic Surgeons supports HR 1127,
legislation introduced by Rep. Greg Ganske, MD (R-Iowa) and Rep.
Ron Wyden (D-Oregon) to amend the current patent law to prohibit
the patenting of medical and/or surgical procedures, and urges
that this legislation be approved by Congress and signed into
public law by the President.

Legal and Ethical References

Applicable provision of the Principles of Medical Ethics
in Orthopaedic Surgery. "IV. The orthopaedic surgeon
must continually strive to maintain and improve medical knowledge
and make relevant information available to patients, colleagues
and the public."

Applicable provision of the Code of Ethics."IV.A.
The orthopaedic surgeon must continually strive to maintain and
improve medical knowledge and skill, and should make available
to patients
and colleagues the benefits of his or her professional attainments."

American Medical Association. Report of the Council on Ethical
and Judicial Affairs, Patenting of Medical Procedures (Informational
Report), June 1995.

U.S. Constitution, Art. 1, Section 8, cl. 8. Congress has
the power to "promote the Progress of Science and useful
Arts, by securing for limited Times to Authors and Inventors the
exclusive Right to their respective Writings and Discoveries."

35 U.S.C. 1101. Any "new or useful process, machine,
manufacture, or composition of matter, or any new and useful improvement
thereof may be patented."